isease for clinically significant decrease in left ventricular function [see Dosageand Administration (2.3) and Warnings and Precautions (5.1)].
Infusion Reactions; Pulmonary Toxicity
Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonarytoxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt TRAZIMERAinfusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completelyresolve. Discontinue TRAZIMERA for anaphylaxis, angioedema, interstitial pneumonitis, or acuterespiratory distress syndrome [see Warnings and Precautions (5.2, 5.4)].
Embryo-Fetal Toxicity
Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramniossequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patientsof these risks and the need for effective contraception [see Warnings and Precautions (5.3) and Use inSpecific Populations (8.1, 8.3)].
1 INDICATIONS AND USAGE
1.1 Adjuvant Breast Cancer
TRAZIMERA is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative(ER/PR negative or with one high risk feature [see Clinical Studies (14.1)]) breast cancer
• as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel ordocetaxel
• as part of a treatment regimen with docetaxel and carboplatin
• as a single agent following multi-modality anthracycline based therapy.Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [seeDosage and Administration (2.1)].
1.2 Metastatic Breast Cancer
TRAZIMERA is indicated:
• In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
• As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one ormore chemotherapy regimens for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [seeDosage and Administration (2.1)].
1.3 Metastatic Gastric Cancer
TRAZIMERA is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment ofpatients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who havenot received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [seeDosage and Administration (2.1)].
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens [seeIndications and Usage (1) and Clinical Studies (14)]. Assessment of HER2 protein overexpression and HER2gene amplification should be performed using FDA-approved tests specific for breast or gastric cancers bylaboratories with demonstrated proficiency. Information on the FDA-approved tests for the detection of HER2protein overexpression and HER2 gene amplification is available at:
http://www.fda.gov/CompanionDiagnostics.
Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer shouldbe performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs. bre |
